MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1266-01-S

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: carto 3 system, model # m-4800-01, s/n: (b)(4).St.Jude medical brk transseptal needle.St.Jude medical sl0 8.5fr sheath.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for paroxysmal atrial fibrillation with a navistar thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis.While ablating around the left pulmonary veins, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram.Pericardiocentesis yielded 800 ml.Remainder of procedure was aborted.Patient was reported to be in stable condition immediately after the intervention.Patient required extended hospitalization (1 day) as a result of the adverse event.Patient fully recovered.Patient was in sinus rhythm during the procedure.Factors cited that may have contributed to the adverse event included a slightly difficult transseptal puncture.Physician did not provide a causality opinion.It was noted that the physician does not believe a bwi product was responsible for the injury.Transseptal puncture was performed with a st.Jude medical brk transseptal needle and a st.Jude medical sl0 8.5 french sheath.Generator parameters and settings at the time of injury were not reported, as the event was not directly related to a specific ablation site.Power was not titrated during ablation.Overall ablation time and last ablation cycle time at the site of injury were not reported, as the site of injury is unknown.Irrigated catheter flow was set at 30 ml/min.Patient received anticoagulant during the procedure with activated clotting time (act) maintained between 300-350 seconds.Act was 330 seconds at the time of injury.There were no errors reported on any bwi equipment during the procedure.

Manufacturer Narrative

On 6/8/2017, the bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for paroxysmal atrial fibrillation with a navistar thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis.The returned device was visually inspected, and it was found in good condition.The catheter was evaluated for carto 3 system performance, and was recognized by the system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.The catheter was tested for electrical performance and stockert compatibility, and was found within specifications.Deflection and irrigation tests were performed, which the catheter passed.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the cardiac tamponade remains unknown.The instructions for use state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6557098
• MDR Text Key: 74829534
• Report Number: 9673241-2017-00369
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(11)170126(17)191231(10)17634731M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17634731M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided; 04/19/2017
• Supplement Dates FDA Received: 06/12/2017; 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR